Principle Regulatory Affairs Associate
Apple
Principle Regulatory Affairs Associate
Job Description
Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices -strengthening our commitment to leave the world better than we found it. The Health group is looking for a Principle Regulatory Affair Associate to support regulated features in China. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. You will be responsible for medical device regulatory affairs activities in China for Apple Health. You will demonstrate the ability to develop a variety of solutions to RA/QA challenges and will exercise independent judgment in settling and communicating appropriate regulator action and engagement strategy.
Locations
- Beijing, Beijing, China 100045
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- develop a variety of solutions to RA/QA challengesintermediate
- exercise independent judgmentintermediate
- settling and communicating appropriate regulator actionintermediate
- engagement strategyintermediate
Required Qualifications
- Bachelor's degree or equivalent in science or engineering. (degree in equivalent in science or engineering)
- 7+ years experience in regulatory affairs. (experience, 7 years)
- Fluent in both English and Chinese (experience)
Preferred Qualifications
- Masters / PhD / post-secondary education preferred. (degree)
- Experience working with the SaMD product or wearable technology. (experience)
- Executive poise and presence, including a track record of positively influencing decisions and teams. (experience)
- Demonstrable background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight. (experience)
- Excellent communication skills, both verbal and written. (experience)
- Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants. (experience)
Responsibilities
- You will be responsible for medical device regulatory affairs activities in China for Apple Health. You will demonstrate the ability to develop a variety of solutions to RA/QA challenges and will exercise independent judgment in settling and communicating appropriate regulator action and engagement strategy.
- Key responsibilities include:
- - Developing submission strategy for assigned product(s)
- - Collaborate with subject matter experts to draft submission documents (e.g. Product Technical Requirements document, Clinical Evaluation Report, etc)
- - Lead in country medical device type testing
- - Oversee submission review progress
- - Lead technical discussions with the regulatory agency and the test lab
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Principle Regulatory Affairs Associate
Apple
Principle Regulatory Affairs Associate
Job Description
Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices -strengthening our commitment to leave the world better than we found it. The Health group is looking for a Principle Regulatory Affair Associate to support regulated features in China. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. You will be responsible for medical device regulatory affairs activities in China for Apple Health. You will demonstrate the ability to develop a variety of solutions to RA/QA challenges and will exercise independent judgment in settling and communicating appropriate regulator action and engagement strategy.
Locations
- Beijing, Beijing, China 100045
Salary
Estimated Salary Rangemedium confidence
2,500,000 - 4,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- develop a variety of solutions to RA/QA challengesintermediate
- exercise independent judgmentintermediate
- settling and communicating appropriate regulator actionintermediate
- engagement strategyintermediate
Required Qualifications
- Bachelor's degree or equivalent in science or engineering. (degree in equivalent in science or engineering)
- 7+ years experience in regulatory affairs. (experience, 7 years)
- Fluent in both English and Chinese (experience)
Preferred Qualifications
- Masters / PhD / post-secondary education preferred. (degree)
- Experience working with the SaMD product or wearable technology. (experience)
- Executive poise and presence, including a track record of positively influencing decisions and teams. (experience)
- Demonstrable background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight. (experience)
- Excellent communication skills, both verbal and written. (experience)
- Apple is an Equal Opportunity Employer that is committed to inclusion and diversity. We also take affirmative action to offer employment and advancement opportunities to all applicants, including minorities, women, protected veterans, and individuals with disabilities. Apple will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation or that of other applicants. (experience)
Responsibilities
- You will be responsible for medical device regulatory affairs activities in China for Apple Health. You will demonstrate the ability to develop a variety of solutions to RA/QA challenges and will exercise independent judgment in settling and communicating appropriate regulator action and engagement strategy.
- Key responsibilities include:
- - Developing submission strategy for assigned product(s)
- - Collaborate with subject matter experts to draft submission documents (e.g. Product Technical Requirements document, Clinical Evaluation Report, etc)
- - Lead in country medical device type testing
- - Oversee submission review progress
- - Lead technical discussions with the regulatory agency and the test lab
Tags & Categories
Answer 10 quick questions to check your fit for Principle Regulatory Affairs Associate @ Apple.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs